ETC / RX - Cardiovascular system - Opecosyl 2, 4, 8
Perindopril tert-butylamine: 2 mg, 4 mg, 8 mg
Stable coronary artery disease: reduction of risk of cardiac events in patients with a history of myocardial infarction and/or re-vascularisation
ADMINISTRATION AND DOSAGE:
The recommended starting dose is 4 mg given once daily in the morning. The dose may be increased to 8 mg once daily after one month of treatment.
For heart failure the dose is 2 mg given once daily in the morning.
In stable coronary artery disease Opecosyl should be introduced at a dose of 4 mg once daily for two weeks, then increased to 8 mg once daily, depending on renal function and provided that 4 mg dose is well tolerated.
Hypersensitivity to any components of this drug or to any other ACE inhibitors.
History of angio-edema associated with previous ACE therapy.
Pregnancy and lactation.
WARNINGS AND PRECAUTIONS:
Cough: Dry cough may occur; in this case the patient must consult again your doctor who will decide if it is reasonable to continue the treatment.
Hypotension: ACE inhibitors may cause a fall in blood pressure. Symptomatic hypotension is seen rarely in uncomplicated hypertensive patients and is more likely to occur in patients who have been volume-depleted e.g. by diuretic therapy, dietary salt restriction, dialysis, diarrhea or vomiting, or who have severe renin-dependent hypertension.
Renal impairment: In cases of renal impairment (creatinine clearance < 60 ml/min) the initial perindopril dosage should be adjusted according to the patient’s creatinine clearance.
Use in children: Efficacy and safety of use in children has not been established.
Headache, fatigue, dizziness, excessive hypotension, gastro-intestinal pain, taste disturbances, dry cough, hyperkalaemia.
Swelling of the face, lips, tongue and/or larynx, which cause difficulty in breathing or swallowing.
Using concomitant potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes may cause increasing in serum potassium.
Diuretics: Patients on diuretics may experience excessive reduction in blood pressure after initiation of therapy with an ACE inhibitor.
Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors.
NSAIDs: The administration of a non-steroidal anti-inflammatory drug may reduce the antihypertensive effect of ACE inhibitors.
Antihypertensive agents and vasodilators: Concomitant use of these agents may increase the hypotensive effects of perindopril. Concomitant use with nitroglycerin and other nitrates, or other vasodilators, may further reduce blood pressure.
Antidiabetic agents: concomitant administration of ACE inhibitors and antidiabetic medicines (insulins, oral hypoglycaemic agents) may cause an increased blood-glucose lowering effect with risk of hypoglycaemia.
Concomitant use of certain anaesthetic medicinal products, tricyclic antidepressants with ACE inhibitors may result in further reduction of blood pressure.
Sympathomimetics may reduce the antihypertensive effects of ACE inhibitors.
Box of 3 blisters x 10 tablets.